Address:3130 GATEWAY DR.,Norcross,GA,30071,US
Device Description : ImmuAdd is intended for use as a potentiator in antibody detection, antibody ide ImmuAdd is intended for use as a potentiator in antibody detection, antibody identification and compatibility procedures. This product is prepared from glycine and salt-poor bovine albumin, and is the ten (10) vial configuration.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Hemantigen (Pooled Cells) is used in the detection of unexpected red blood cell Hemantigen (Pooled Cells) is used in the detection of unexpected red blood cell blood group antibodies for blood donors. Hemantigen is a single vial pool of equal amounts of reagent red blood cells from two (2) group O donors.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Checkcell is used to confirm the validity of negative antiglobulin tests. Checkc Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Checkcell is used to confirm the validity of negative antiglobulin tests. Checkc Checkcell is used to confirm the validity of negative antiglobulin tests. Checkcell is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the one (1) vial configuration.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is used to confirm the validity of negative antiglobulin tests. Checkcell (Weak) is a single vial pool of group O red blood cells that have been sensitized with an IgG antibody. This product is the three (3) vial configuration.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : Bovine Albumin Solution 22% is intended for use as a high protein potentiator in Bovine Albumin Solution 22% is intended for use as a high protein potentiator in crossmatch, antibody identification and antibody titration procedures. This product is prepared from bovine serum albumin and is the ten (10) vial configuration.
Device Class : 2
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : This product is used in the identification of unexpected red cell blood group an This product is used in the identification of unexpected red cell blood group antibodies. This product is manufactured as 16 vials of reagent in a set. Reagent red blood cell vials each contain a 2-4% suspension of group O red blood cells prepared in a buffered preservative solution.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : This configuration of the product contains four (4) vials, and is used for the c This configuration of the product contains four (4) vials, and is used for the confirmation of reverse expected ABO serum grouping antibodies.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes
Device Description : This configuration of the product contains one (1) vial, namely known A2 red blo This configuration of the product contains one (1) vial, namely known A2 red blood cells, and is used for the confirmation of reverse expected ABO serum grouping antibodies.
Device Class :
Duns Number: 061446282
Premarket Exempt : No
Prescription Use : Yes